Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04564118
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2020-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Retrospective Analysis of the Adherence to Clinical Practice Guidelines Using the "MedicBK" Digital Platform in Patients With Hypertension and Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 191}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of AF/AH treatment guidelines compliance', 'timeFrame': '1 MONTH', 'description': 'Number of electronic medical records not compliant to the AF/AH clinical practice guidelines'}], 'secondaryOutcomes': [{'measure': 'Assessment of MedicBK programme', 'timeFrame': '1 MONTH', 'description': "Number of prescriptions from electronic medical records appropriate or inappropriate according to the AF/hypertension clinical practice guidelines in comparison with the treatment's choice of CDSS platform"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'arterial hypertension', 'digital medicine', 'Clinical Decision Support System'], 'conditions': ['Atrial Fibrillation', 'Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'The Clinical Decision Support Systems (CDSS) based on real clinical data and its own algorithms can help to make the right choice. This trial is designed to assess the difference between retrospective electronic medical cards (EMC) therapy prescriptions and MedicBK prescriptions based on key patient characteristics.', 'detailedDescription': "There is a lot of data from registries about poor adherence to guidelines. It is connected with a problem that patients usually have a lot of comorbidities and physicians need to know сonsequently the huge number of medications and combinations. It is very difficult to decide quickly according to available data from libraries like PubMed. The Clinical Decision Support Systems (CDSS) based on real clinical data and its own Artificial Intelligence algorithms can help to make the right choice. This trial is designed to assess the difference between retrospective electronic medical cards (EMC) therapy prescriptions and MedicBK prescriptions based on key patient characteristics.\n\nTwo groups of experts (cardiologists with clinical practice for more than 5 years) will be participating in the trial.\n\nUsing main characteristics from EMC the first group of experts will put this data into MedicBK platform and assess retrospective treatment. The next blinded group of experts will perform prescriptions using MedicBK algorithms based on current guidelines and data from available clinical trials. The main hypothesis is the use Clinical Decision Support Systems (CDSS) better than current clinical practice. This option can help to make the right choice of medical combination based on main patient's clinical characteristics"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with nonvalvular atrial fibrillation and essential hypertension having indications for therapy according to European guidelines', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18 years old\n2. Patients diagnosed with nonvalvular atrial fibrillation and essential hypertension having indications for therapy according to European guidelines.\n\nExclusion Criteria:\n\n1. Valvular cause of atrial fibrillation\n2. GFR less than 30 ml / min\n3. Active liver disease\n4. Acute coronary syndrome\n5. The presence of thyroid diseases as a cause of atrial fibrillation\n6. Secondary arterial hypertension'}, 'identificationModule': {'nctId': 'NCT04564118', 'acronym': 'INTELLECT', 'briefTitle': 'A Retrospective Analysis of the Adherence to Clinical Practice Guidelines Using the "MedicBK" Digital Platform in Patients With Hypertension and Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health'}, 'officialTitle': 'A Retrospective Analysis of the Adherence to Clinical Practice Guidelines Using the "MedicBK" Digital Platform in Patients With Hypertension and Atrial Fibrillation (the INTELLECT Trial)', 'orgStudyIdInfo': {'id': '909-2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'retrospective data on treatment from EMC', 'interventionNames': ['Drug: Retrospective analysis of assigned treatment']}, {'label': 'Group 2', 'description': 'Treatment assignment using medicBC CDSS platform in the same cohort of patients'}], 'interventions': [{'name': 'Retrospective analysis of assigned treatment', 'type': 'DRUG', 'description': 'analysis of treatment assigned by physicians within routine clinical practice', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '197341', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'V.A. Almazov Fnmrc', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medicbook LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}